MedTrace Logo

The Inflammatory Process and the Medical Imaging in Patients With an Inflammatory Disease of the Central Nervous System.

NCT01567553 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2015-10-28

No results posted yet for this study

Summary

While significant progress has been made on medical imagery in recent years in the individualization of different lesions in the nervous system for demyelination, axonal loss, atrophy, little progress has been made in the specific recognition the inflammatory process. Yet this point is essential since the currently available treatments have a partial impact mainly on the inflammatory component and that many uncertainties remain about the links between inflammation and tissue destruction affecting myelin and axons. The recent discovery of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the opportunity to answer important questions which one can sense that this could have a significant impact on therapeutic drug monitoring of these patients. This study will involve 50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse) from the earliest manifestations of the disease with clinical and MRI scheduled for the first 3 years of their disease.

Conditions

  • Multiple Sclerosis (MS)
  • Inflammatory Disease

Interventions

OTHER

USPIO MRI - Gadolinium MRI

USPIO MRI scanning will be performed at : * baseline, month 3, month 6, month 9 and month 12 for patients recruited prior to the 1st of May 2010. * baseline, month3, month 6 and month 9 for patients recruited between the 1st of May 2010 and the 31st of July 2010, * baseline, month 3 and month 6 for patients recruited between the 1st of August 2010 and the 31st of October 2010, * baseline and month 3 for patients recruited between the 1st of November 2010 and the 31st of January 2011, * baseline for patients recruited between the 1st of February 2011 and the 30rd of April 2011. Gadolinium MRI scanning will be performed at baseline, month 3, month 6, month 9, month 12, month 18, month 24 and month 36.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • EDAN Gilles · Rennes University Hospital

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-06-30
Completion
2015-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567553 on ClinicalTrials.gov